High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

May 21, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

A Randomized High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial)

The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients and non-small cell lung cancer (NSCLC) patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiation and NSCLC patients receiving immunotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for GI Patients:

  • 18 years of age or older
  • Diagnosed with locally advanced rectal cancer (Stage II-III)
  • Will undergo neoadjuvant chemoradiation at Moffitt Cancer Center
  • Able to pick up FFs once/weekly at Moffitt
  • Able to speak and read English
  • Able to consume foods orally
  • Able to provide informed consent

Inclusion Criteria for Thoracic Patients:

  • 18 years of age or older
  • Diagnosed with stage II-IV non-small cell lung cancer (NSCLC)
  • Will undergo Immunotherapy with immune checkpoint inhibitors (+/- chemotherapy or other treatment) at Moffitt Cancer Center
  • Able to pick up FFs once/weekly at Moffitt
  • Able to speak and read English
  • Able to consume foods orally
  • Able to provide informed consent

Exclusion Criteria:

  • Antibiotic use within 1 month prior to baseline
  • If currently using probiotics, unwillingness to cease probiotic use
  • Previous receipt of surgery, immunotherapy, chemotherapy, or radiation for a colon or rectal tumor
  • Per clinician's discretion, clinician confirmed inflammatory bowel conditions (e.g., ulcerative colitis, Crohn's disease)
  • Infectious disease diagnosed <1 month prior to baseline
  • Already consuming ≥2 servings of fermented foods/day
  • Previously diagnosed with a mast cell disorder or histamine allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FEED-FF

Participants will be asked to pick up the fermented foods at the Research Kitchen at Moffitt. Participants will be asked to eat 3-6 servings of FFs per day, from 1 week prior to treatment start through 12 weeks after treatment start/until the restaging scope is completed.

At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic.

Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints.

After the dietary intervention, participants will be asked to complete an exit survey to provide feedback on the study and intervention.
Other: FEED-FF
3-6 servings of any combination of the following fermented foods/day (from 1 week prior to treatment to approximately 12 weeks after the start of treatment): Yogurt, cottage cheese, kefir, kombucha, sauerkraut, and kimchi.
Active Comparator: Standard of Care (SUC)

Participants will receive general healthy eating handouts similar to current usual care documents provided in clinic.

These handouts will detail typical healthy foods and the suggested level of intake, or servings per day.

At baseline, the end of week 6.5 and again at week 12.5, participants will be asked to provide biospecimens including a stool sample collected at home and a blood specimen collected in clinic. Participants will be asked to complete a food frequency questionnaire, a quality-of-life survey, two symptom related surveys, and a stool collection questionnaire at these same timepoints.
Other: Standard of Care (SUC)
Standard of Care (SUC) is the treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by health care professionals. Standard of Care will comprise general healthy eating handouts that describe typical healthy foods and the suggested level of servings per day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effects of FEED-FF diet on the gut microbiome
Time Frame: At Baseline, Week 6.5 and Up to 12.5 Weeks
Measured by fecal biospecimen sample collection; FEED-FF arm hypothesized to demonstrate increases in short chain fatty acid (SCFA) producing bacteria and higher alpha diversity compared to SUC arm.
At Baseline, Week 6.5 and Up to 12.5 Weeks
Effects of FEED-FF diet on local immune-related biomarkers
Time Frame: At Baseline and Up to 12.5 Weeks
Measured by FFPE tissue slides; FEED-FF arm hypothesized to demonstrate enhanced immune response such as higher T-cell expression compared to SUC arm.
At Baseline and Up to 12.5 Weeks
Effects of FEED-FF diet on quality of life
Time Frame: At Baseline, Week 6.5 and Up to 12.5 Weeks
Measured by using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Survey; FEED-FF arm hypothesized to demonstrate more favorable QoL compared to SUC arm.
At Baseline, Week 6.5 and Up to 12.5 Weeks
Efficacy of the FEED-FF intervention
Time Frame: At Baseline, Week 6.5 and Up to 12.5 Weeks

Measured by an accrual rate of 50% of eligible patients, fermented foods (FF) intake of at least 3 servings on at least 80% of days, and at least 80% of intervention group reporting high/very high satisfaction with intervention.

Weekly goal adherence via randomly administered food logs, tracking responses to and general completion of an exit survey will be utilized.
At Baseline, Week 6.5 and Up to 12.5 Weeks
Feasibility of the FEED-FF intervention
Time Frame: At Baseline, Week 6.5 and Up to 12.5 Weeks

Measured by an accrual rate of 50% of eligible patients, fermented foods (FF) intake of at least 3 servings on at least 80% of days, and at least 80% of intervention group reporting high/very high satisfaction with intervention.

Weekly goal adherence via randomly administered food logs, tracking responses to and general completion of an exit survey will be utilized.
At Baseline, Week 6.5 and Up to 12.5 Weeks
Effects of the FEED-FF diet on clinical response to chemoradiation (Rectal Cancer Patients)
Time Frame: At Baseline and Up to 12.5 Weeks

Clinical response measured in clinic by MRI/Endoscopy/Digital rectal exam, comparing the FEED-FF arm to SUC arm.

Indicators of clinical response are Complete Response, Near Complete Response, Incomplete Response, or Progressive Disease.
At Baseline and Up to 12.5 Weeks
Effects of the FEED-FF diet on clinical response to immunotherapy (Lung Cancer Patients)
Time Frame: At Baseline and Up to 12.5 Weeks

Clinical benefit to immune checkpoint inhibitor therapy will be measured in clinic by MRI/Endoscopy, comparing the FEED-FF arm to SUC arm.

Defined as the best response of complete tumor resolution (CR), Partial Response (PR), and stable tumor size (SD) within 12 months.

Progressive Disease (PD) within 12 months indicates no clinical benefit.
At Baseline and Up to 12.5 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Doratha (Armen) Byrd, PhD, MPH, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-22709

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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